In the performance of cholecystectomy surgery a certain percentage of patients who undergo the operation will have gallstones that have migrated from their gallbladder to the common bile duct. The stones may spontaneously pass through the distal end of the bile duct into the duodenum causing no harm or they may be trapped in the common bile duct by the sphincter muscle at the distal end of the duct. In the event the sphincter muscle gets irritated by the stones, the muscle will trap them and prevent them from passing into the duodenum. The trapping of the stones backs up the common bile duct thereby causing jaundice, pancreatitis and cholangitis.
Removal of the stones which had entered the common bile duct required that the surgeon make a large abdominal incision, remove the gallbladder, and then cut open the common bile duct. The surgeon would thereafter retrieve the stones one by one from the common bile duct by grasping the stones or using balloon catheters to pull them retrograde. Alternatively, the stones could be removed by resorting to endoscopic retrograde cholangiopancreatography-sphincterotomy (ERCP).
In retrieving the stones from the common bile duct by using the balloon catheters, the surgeon would extend the balloon portion of the catheter into the common bile duct beyond the stone, and thereafter inflate the balloon. The stone would then be withdrawn retrograde through the common bile duct and through the incision which was made in the common duct for inserting the catheter. In order for the choledochotomy incision in the common bile duct to heal properly, a T-tube was inserted in the common duct and left in place for approximately three weeks after the surgery which resulted in significant disability. The ERCP procedure to remove stones from the common bile duct required that an endoscope be passed through the patient's mouth, down through the stomach and into the duodenum. After identifying the ampulla of Vater, which is where the common bile duct drains into the duodenum, the endoscopist would then cannulate the ampulla and inject dye into the common duct retrograde and visualize the stones on fluorscopic x-ray. After the stones were found on x-ray, a cut was then made in the sphincter muscle in the distal bile duct from an instrument passed through the endoscope. By cutting the muscle, there was no longer a restriction to the flow of stones and the stones were therefore allowed to pass into the duodenum. This procedure involved an 8% morbidity and a 1% mortality risk to the patient most often due to severe pancreatitis.
A method for removing common duct stones laparoscopically has been used requiring a cholangiography to be first performed by passing a catheter through the cystic duct and then injecting dye into the common duct to visualize the stones flouorscopically. When the stones are identified in the common duct, a balloon dilating catheter is thereafter passed into the cystic duct and dilated sufficiently to permit the insertion of an endoscope through the cystic duct and into the common bile duct. By transcystic endoscopic common bile duct exploration, the stones are visually identified by the surgeon through the endoscope and thereafter grasped by a basket-type retriever and removed. There are limitations, however, to this procedure for transcystic common bile duct exploration. The procedure will fail if the cystic duct is too small to be dilated to sufficient size to allow the endoscope to enter into the common bile duct. In other cases, the stones may be too small to be grasped by the basket retriever. When stones of a very small diameter are stuck in the sphincter muscle at the distal end of the common bile duct, it is extremely difficult to retrieve the stones endoscopically.
Dilation of the sphincter muscle has been performed through the oral insertion of an endoscope that passed down through the stomach into the duodenum where the endoscope included a balloon means which was inserted retrograde into the common bile duct through the sphincter muscle. This technique resulted in an unacceptable complication rate which included complications such as pancreatitus and cholangitis.
Catheter devices in the prior art which utilize balloons in the removal of common bile duct stones used the balloons for withdrawing stones retrograde or blocking passages. In U.S. Pat. No. 4,725,264, entitled "Double Barreled Biliary Balloon Catheter" a catheter was designed to remove gallstones which had obstructed the common bile duct. The catheter balloon was attached to a filiform probe which had passed beyond the stones and the catheter balloon was then positioned beneath the stone, inflated and the entire assembly was then drawn upwardly until the stone had fallen out of the encised opening in the common duct. Similarly, in U.S. Pat. No. 4,627,837, entitled "Catheter Device", the catheter device was equipped with a pair of balloons which were inflatable from the proximal end of the catheter where one balloon acted as an anchor to retain the catheter in the ampulla and a second balloon was inflated beneath the stone and the stone withdrawn retrograde and removed through the choledochotomy incision. A double lumen catheter is descibed in U.S. Pat. No. 4,919,651, having a balloon at one end and a bifurcated inlet connector at the other for the controlled filling of the biliary ductal system with a dilute dye for operative cholangiography. In this device, the catheter was drawn retrograde until the expanded balloon impinged upon and sealed an opening.
An internal mammary artery catheter is shown in U.S. Pat. No. 4,909,258 for performing selective arteriography or angioplasty on internal mammary or artery graft. The catheter utilizes a balloon and a proximal port. The port delivers an anglographic dye for visualizing vascular obstructions to the internal mammary artery or graft within the subclavian artery. The catheter is inserted over a guidewire into the subclavian artery and the balloon inflated at a point distal to the junction of the subclavian artery and the internal mammary artery. The balloon is inflated to obstruct blood flow to an axillary artery and thereafter an angiographic dye is injected through the proximal port for visualizing the angiographic dye using radiography. Thus, the catheters of the prior art have utilized a balloon for the purpose of removing stones from the common bile duct by retrograde movement of the balloon to pull the stone back through the incision in the common duct. In some instances, this procedure required the installation of a T-tube which was left in place for a period of at least 3 weeks after the surgery. Other procedures of the prior art required that a cut be made in the sphincter muscle in the distal bile duct by utilizing an instrument passed through an endoscope. By cutting the sphincter muscle the patient was exposed to the risk of severe pancreatitis with the possibility of serious morbidity and even mortality.